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Completed

NCT Number: NCT06364943

Tear Ferning Test for Dry Eye Diagnosis

Application of tear ferning test for clinical dry eye diagnosis

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jen-Ai Hospital

Taichung, 412, Taiwan

About this study

Comparing dry eye patients' tear ferning structure with non-dry eye patients' to develop a protocol for easy and costless diagnosis in ophthalmology.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 20 and 65 years
  • For dry eye disease group:
  • Schirmer's test results between 5 - 10 mm
  • Tear Film Break Up Time less than 10 seconds
  • Ocular Surface Disease Index of more than 25

Exclusion criteria

  • Those have diabetes, hypertension or other chronic diseases
  • No evident ocular diseases such as cornea disease, cataracts, vitreous degeneration, glaucoma, and retinopathy.
  • Belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)

Treatment and study plan

with/without dry eye syndrome

Other

compare tear ferning structure between dry eye and non-dry eye patients

Primary outcomes

  1. Schirmer's test

    Time frame: 5 minutes

    to assess tear secretion volume

  2. Tear film breakup time

    Time frame: 20 seconds

    to assess tear quality

  3. Ocular surface health evaluate

    Time frame: 3 minutes

    To assess the health status with Lissamine green stain

Secondary outcomes

  1. Ocular surface disease index

    Time frame: 20 minutes

    A questionnaire to assess the health status on ocular surface

    A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.

  2. Intraocular pressure

    Time frame: 2 minutes

    to determine the effects of intervention on intraocular pressure

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

Application of Tear Ferning Test for Clinical Dry Eye Diagnosis

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 15, 2024
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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